WO2002103029A3 - Methods for sterilizing preparations of monoclonal immunoglobulins - Google Patents

Methods for sterilizing preparations of monoclonal immunoglobulins Download PDF

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Publication number
WO2002103029A3
WO2002103029A3 PCT/US2002/018823 US0218823W WO02103029A3 WO 2002103029 A3 WO2002103029 A3 WO 2002103029A3 US 0218823 W US0218823 W US 0218823W WO 02103029 A3 WO02103029 A3 WO 02103029A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
monoclonal immunoglobulins
sterilizing preparations
sterilizing
preparations
Prior art date
Application number
PCT/US2002/018823
Other languages
French (fr)
Other versions
WO2002103029A2 (en
Inventor
Teri Grieb
Wilson H Burgess
William N Drohan
Ren-Yo Forng
Martin J Macphee
David M Mann
Anna Mcbain
Original Assignee
Clearant Inc
Teri Grieb
Wilson H Burgess
William N Drohan
Ren-Yo Forng
Martin J Macphee
David M Mann
Anna Mcbain
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Clearant Inc, Teri Grieb, Wilson H Burgess, William N Drohan, Ren-Yo Forng, Martin J Macphee, David M Mann, Anna Mcbain filed Critical Clearant Inc
Priority to AU2002322094A priority Critical patent/AU2002322094B2/en
Priority to MXPA03011617A priority patent/MXPA03011617A/en
Priority to CA002450730A priority patent/CA2450730A1/en
Priority to KR10-2003-7016413A priority patent/KR20040043127A/en
Priority to JP2003505350A priority patent/JP2005517631A/en
Priority to EP02756185A priority patent/EP1425041A2/en
Publication of WO2002103029A2 publication Critical patent/WO2002103029A2/en
Publication of WO2002103029A3 publication Critical patent/WO2002103029A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A61L2/0035—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

Methods are disclosed for sterilizing preparation of monoclonal immunoglobulins to reduce the level of active biological contaminants such a viruses, bacteria, yeasts, molds, mycoplasmas, prions and parasites.
PCT/US2002/018823 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins WO2002103029A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AU2002322094A AU2002322094B2 (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins
MXPA03011617A MXPA03011617A (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins.
CA002450730A CA2450730A1 (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins
KR10-2003-7016413A KR20040043127A (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins
JP2003505350A JP2005517631A (en) 2001-06-14 2002-06-13 Method for disinfecting monoclonal immunoglobulin preparations
EP02756185A EP1425041A2 (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/880,052 2001-06-14
US09/880,052 US6696060B2 (en) 2001-06-14 2001-06-14 Methods for sterilizing preparations of monoclonal immunoglobulins

Publications (2)

Publication Number Publication Date
WO2002103029A2 WO2002103029A2 (en) 2002-12-27
WO2002103029A3 true WO2002103029A3 (en) 2004-03-18

Family

ID=25375418

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/018823 WO2002103029A2 (en) 2001-06-14 2002-06-13 Methods for sterilizing preparations of monoclonal immunoglobulins

Country Status (9)

Country Link
US (3) US6696060B2 (en)
EP (1) EP1425041A2 (en)
JP (1) JP2005517631A (en)
KR (1) KR20040043127A (en)
CN (1) CN1541110A (en)
AU (1) AU2002322094B2 (en)
CA (1) CA2450730A1 (en)
MX (1) MXPA03011617A (en)
WO (1) WO2002103029A2 (en)

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US20110091353A1 (en) * 2001-09-24 2011-04-21 Wilson Burgess Methods for Sterilizing Tissue
US20030185702A1 (en) * 2002-02-01 2003-10-02 Wilson Burgess Methods for sterilizing tissue
US20030180181A1 (en) * 2002-02-01 2003-09-25 Teri Greib Methods for sterilizing tissue
US20040126880A1 (en) * 2002-06-07 2004-07-01 Manders Ernest K. Sterilization, stabilization and preservation of functional biologics
US20040013561A1 (en) * 2002-07-18 2004-01-22 David Mann Methods for sterilizing recombinant or transgenic material
JP5247031B2 (en) 2004-01-22 2013-07-24 ユニバーシティー・オブ・マイアミ Topical coenzyme Q10 formulation
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EP1425041A2 (en) 2004-06-09
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